Potassium-Competitive Acid Blocker for Nonerosive Reflux Disease

Nonerosive reflux disease (NERD) is characterized by the presence of classic gastroesophageal reflux disease symptoms but the absence of erosive esophagitis on endoscopy. The primary aim of this study was to assess the efficacy of the potassium-competitive acid blocker vonoprazan in patients with NERD.

This multicenter trial, conducted at 91 centers, included patients with NERD who were randomized to receive 10 or 20 mg of vonoprazan or placebo for 4 weeks. After this initial period, patients who had received the placebo were randomized to receive 10 or 20 mg of vonoprazan for an extension period of 20 weeks, while the patients who initially received vonoprazan continued their same treatment. Patients kept electronic diaries and recorded any heartburn symptoms and use of rescue antacids twice daily.

The results showed that of the randomized patients, 739 completed the initial 4 weeks, and 728 were rerandomized to vonoprazan therapy for the extension phase. During the initial phase, the percentage of 24-hour heartburn symptom-free days was 27.7% for placebo, 44.8% for 10 mg of vonoprazan (least squares mean difference, 17.1%; P < .0001), and 44.4% for 20 mg of vonoprazan (least squares mean difference, 16.7%; P < .0001). The mean and median percentages of 24-hour heartburn-free days over the extension period were similar across the study arms.